Remote Mindfulness Training Following Early Life Adversity 2

NCT ID: NCT07085052

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-12-16

Brief Summary

This pilot study aims to evaluate the effects of a 10-week online Mindfulness-Based Stress Reduction (MBSR) intervention on stress and inflammatory outcomes in a sample of emerging adults with a history of early life adversity. 15 participants (ages 18-29) with a history of childhood trauma will receive online, group-based MBSR sessions over 10 weeks. At pre- and post-intervention, participants will complete laboratory assessments, including self-report questionnaires and blood sample collection to assess markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected for one week at pre- and post-intervention. This preliminary data will be used to test effects of online MBSR on health-relevant outcomes among young adults with a history of childhood trauma.

Conditions

Stress; Mindfulness; Early Life Adversity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Stress Reduction (MBSR)

MBSR is a standardized curriculum-based group program. In this study, MBSR will be adapted to include 10 (rather than the standard 8) weekly 2.5-hour group sessions delivered online, plus a day-long online retreat and 30-45 minutes of home practice assignments six days per week. MBSR includes guided mindfulness meditations intended to foster awareness of present-moment experiences and an open, accepting, and nonjudgmental perspective. Guidance and group discussions also encourage nonjudgmental awareness in everyday life, including when experiencing stress or other challenging emotions. Group discussions involve exploration of habitual reactions to stress and the cultivation of skills such as pausing before responding. Foundationally, the course centers on self-care and group support, including support for the challenge of integrating meditation practice into daily life. Home practice recordings will guide participants through body awareness, mindful movement, and seated meditation.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: BEHAVIORAL

10-week online MBSR program, involving 10 weekly 2.5-hour group sessions, a day-long online retreat, and approximately 45 minutes of home practice assignments six days per week.

Interventions

Mindfulness-Based Stress Reduction (MBSR)

10-week online MBSR program, involving 10 weekly 2.5-hour group sessions, a day-long online retreat, and approximately 45 minutes of home practice assignments six days per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 18-29 years
• English speaking
• History of adverse childhood experiences (specifically, moderate-to-severe physical, emotional, or sexual abuse in childhood: scoring >9, >12, or >7 on respective Childhood Trauma Questionnaire subscales)
• Data-enabled Android or iOS smartphone
• Able to meet study requirements

Exclusion Criteria

• Self-reported diagnosis of chronic physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
• Self-reported diagnosis of chronic mental disorder (e.g., schizophrenia, personality disorder, or psychotic illness), major neurological disorder, or suicidal thoughts or wishes at baseline
• Medication use that interferes with HPA-axis activity (e.g., corticosteroids), autonomic activity (e.g., antihypertensive medication), inflammatory activity (e.g., cholesterol medications), or blood clotting
• Current antibiotic, antiviral, or antimicrobial treatment
• Shift workers
• Pregnancy
• Substance use disorder
• Regular systematic mind-body practice (>2 times per week)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Emily Lindsay

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily K Lindsay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY25020112

Identifier Type: -

Identifier Source: org_study_id